Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT01002495
Status:
WITHDRAWN
Last Update Posted:
2025-09-25
First Post:
2009-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Therapy for the Treatment of Chronic Stable Angina
Sponsor:
Helixmith Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I/II Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Subjects With Chronic Refractory Myocardial Ischemia
Status:
WITHDRAWN
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was never initiated at any sites.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of catheter based injections of VM202 into the heart.
Detailed Description:
A phase I/II, open label, dose-escalation, multicenter, 12 month study designed to assess the safety and tolerability of catheter based percutaneous myocardial injection of VM202 in patients with chronic refractory myocardial ischemia. The study will consist of three (3) cohorts with a total of 4 subjects enrolled in each cohort. Endocardial injections will be performed with the MyoStar Injection Catheter under guidance of the NOGA XP Cardiac Navigation System.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: